This clinical trial conducted on female patients with migraine headaches which is aggravated in menstrual period in spite of treatment for migraine prophylaxis with aim of finding a proper solution for alleviation of their pain .
Design
This randomized double blind clinical trial is conducted on two intervention and control groups in parallel for three months. Selection of patients with migraine is according to international headache society (IHS) criteria.Patients who against treatment for prophylaxis of migraine feel progress of symptom after selection according mentioned criteria are assigned randomly by the use of chart of random numbers in two group equally and fifty patients in each group. All patients take Nortriptiline 0.6 milligram /kilograms at night and Propranolol one milligram/kilograms/day divided to two equal dose . Patients in intervention group take Acetazolamide two hundred and fifty milligrams three times daily which is started three days before usual time of menstruation in each patient to the end of menstrual period in addition to above mentioned drugs. In control group patients take Placebo with the same figure, dose and period in addition to above mentioned drugs.
Settings and conduct
Study is a double blind clinical trial which will be carry out in neurology clinic of mostafa khomeini hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients are between eighteen to forty-five years old with at least three attacks of headache in one month and at least one year history of migraine.Exclusion criteria: Patients with an abnormal findings in neurological exams unrelated to migraine, use of any other drugs at the beginning of study, other types of head or facial pains, ,menstrual period less than five days and any history of hypersensitivity to Acetazolamide are not permitted.
Intervention groups
َAll Patients in both study and control groups take Nortriptiline 0.6 milligram /kilograms at night and Propranolol one milligram/kilograms/day divided to two equal dose this dose selection by weight is for patient safety and never more than standard permitted dose. Patients in study group in addition to drugs mentioned above take Acetazolamide two hundred and fifty milligrams three times daily which is started three days before usual time of menstruation in each patient to the end of menstrual period. In control group patients take placebo three times daily with similar figure and weight in the same period similar to intervention period in addition to above mentioned drugs.
Main outcome variables
Headache intensity
Headache frequency according to number of attacks in one month
Headache duration in hour
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161103030680N8
Registration date:2018-02-11, 1396/11/22
Registration timing:retrospective
Last update:2018-02-11, 1396/11/22
Update count:0
Registration date
2018-02-11, 1396/11/22
Registrant information
Name
Siamak Afshinmajd
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8896 9438
Email address
afshin@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor of research. Shahed University
Expected recruitment start date
2013-08-12, 1392/05/21
Expected recruitment end date
2016-04-09, 1395/01/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of acetazolamide efficacy in migraine headaches in menstrual period
Public title
Migraine in menstrual period
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Migraine headaches according to International headache society criteria
At least one year history of migraine headaches
At least three attacks of headaches in one month
Exacerbation of headaches during menstrual periods
Age between eighteen to forty-five years old
Exclusion criteria:
Use of any other drugs at the beginning of study
Other types of headaches or facial pain
Intolerance or allergy to drugs which are used in study
Abnormal neurologic exam which is unacceptable in migraine
Menstrual period shorter than five days
Age
From 18 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Patients with migraine headache who attend in neurology clinic of Mostafa Khomeini hospital and are selected according to study criteria are given a number and then by use of chart of random numbers are assigned randomly in study and control groups. The group of first patient is selected by lottery.
Blinding (investigator's opinion)
Double blinded
Blinding description
ِDrugs are inserted in uniform packages and code is assigned. Patients researchers and assessors are not aware of patient group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahed University
Street address
Entrance of Tehran - Qom Highway
City
Tehran
Province
Tehran
Postal code
3319118651
Approval date
2013-04-10, 1392/01/21
Ethics committee reference number
Shahed.REC.1391.37
Health conditions studied
1
Description of health condition studied
Migraine headaches
ICD-10 code
G43
ICD-10 code description
Migraine without aura (common migraine)
2
Description of health condition studied
Migraine headaches
ICD-10 code
G43.1
ICD-10 code description
Migraine with aura (classic migraine)
Primary outcomes
1
Description
Headache Intensity
Timepoint
Third day after beginning of treatment with acetazolamide and fifth day of menstruation in both groups.
Method of measurement
Visual Analougue Scale
2
Description
Headache duration
Timepoint
At first day before beginning of treatment and at the end of each treatment episode.
Method of measurement
Mean duration of attacks in hour according to patients claims.
3
Description
Headache Intensity
Timepoint
Third day after beginning of treatment and fifth day of menstruation
Method of measurement
6 Points Behavioral Rating Scale
4
Description
Headache frequency
Timepoint
At first day before beginning of treatment and at the end of each treatment episode
Method of measurement
Number of headache attacks
Secondary outcomes
1
Description
Allergic drug reactions (Pruritus, Redness of skin, Urticaria)
Timepoint
Instantly after alarm of the patient
Method of measurement
Observation, examination and consultation with proper specialist
Intervention groups
1
Description
Control group:Fifty patients with migraine headaches which is aggravated during menstrual periods take Nortriptiline 0.6 milligrams / kilogram at night and Propranolol one milligrams / kilogram per day divided to two equal dose for three months. َAll patients in this group takes placebo three times daily from three days prior the usual time of menstrual period for each patient to the end of period in addition to above mentioned drugs
Category
Treatment - Drugs
2
Description
Intervention group: Fifty patients with migraine headaches which is aggravated during menstrual periods take Nortriptiline 0.6 milligrams / kilogram at night and Propranolol one milligrams / kilogram per day divided to two equal dose for three months. ََAll patients in this group take Acetazolamide two hundred and fifty milligrams three times daily from three days before the usual time for beginning of menstrual period to the end of period in addition to above mentioned drugs.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mostafa khomeini hospital
Full name of responsible person
Siamak Afshinmajd
Street address
Italia street. Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1416643491
Phone
+98 21 8896 9438
Email
safshinmajd@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahed University
Full name of responsible person
Zahra Kiasalari
Street address
Entrance of Tehran -Qom Highway
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 5080
Email
kiasalari@shahed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Siamak Afshinmajd
Position
Associate Professor of Neurology
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Italia street. Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1416643491
Phone
+98 21 8896 9438
Fax
Email
safshinmajd@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Siamak Afshinmajd
Position
Associate Professor of Neurology
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Italia street. Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1416643491
Phone
+98 21 8896 9438
Fax
Email
safshinmajd@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Siamak Afshinmajd
Position
Associate Professor of Neurology
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Italia street. Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1416643491
Phone
+98 21 8896 9438
Fax
Email
safshinmajd@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available